Today, a magistrate judge in the Northern District of Texas recommended that the district court accept Gary D. Osborn's guilty plea to a two-count information, charging violations of 21 U.S.C. Section 331(a), 352(a) and 333(a)(1)--all criminal, class A misdemeanors--for introducing in interstate commerce a misbranded drug in that its label was false and misleading. Click here to see Report and Recommendation of magistrate judge. As noted in previous blogs three people died because of misbranded colchicine injectable solution compounded at ApothéCure, Inc., where Osborn was a pharmacist. Osborn was released on conditions that are typical of this type of case. The next step is that the district court will most likely accept the magistrate judge's report and recommendation, thus accepting Osborn's guilty plea and then impose sentence.
Readers feel free to comment on whether pharmacists and companies that compound medications should be held criminally responsible in these types of cases? Should criminal charges be brought only in cases where death or serious bodily injury results? Does it matter if the death or serious bodily injury is that of an animal instead of a human? Should a company be shut down if a death or serious bodily injury results?
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